FDAnews Drug Daily Bulletin

FDA WILL IMPLEMENT COUNTERFEIT RX PEDIGREE REQUIREMENTS

June 13, 2006
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Following the recommendations of a report just released by its Counterfeit Task Force, the FDA has decided to allow pedigree requirements for prescription drugs to go into effect in December because pharmaceutical manufacturers have failed to adopt the electronic track-and-trace technology on the scale the agency urged them to implement by 2007.

The FDA also said it would establish priorities for its pedigree-enforcement program by focusing its resources on the drug products that are most likely to be counterfeited or diverted.

A pedigree is a record of all transactions a drug goes through, from the manufacturing plant to the dispensing pharmacy. The 1987 Prescription Drug Marketing Act (PDMA) established paper pedigree requirements. Under the requirement, each person who is engaged in the wholesale distribution of a prescription drug in interstate commerce, who is not the manufacturer or an authorized distributor of record for that drug, must provide to the person who receives the drug a pedigree for that drug. The PDMA states that an authorized distributor of record is a wholesaler that has an "ongoing relationship" with a manufacturer to distribute that manufacturer's drug. However, the PDMA does not define "ongoing relationship."

The FDA issued final regulations governing pedigrees in 1999 that were to go into effect in December 2000. However, after receiving negative comments on the regulations, the agency delayed the effective date several times.

In February 2004, the FDA again delayed the effective date, believing the industry would voluntarily adopt electronic track-and-trace technology. In fact, the agency urged industry to adopt such technology -- giving special emphasis to radio-frequency identification tags -- in its final Counterfeit Drug Task Force report issued that same month. A recent report found that only about 10 prescription drug products are expected to contain RFID tags on a large scale this year.

But the FDA said it will not stay the pedigree requirement after Dec. 1 of this year, meaning wholesalers who are not authorized distributors will have to provide pedigrees.

The agency also issued a draft compliance policy guide for public comment in which it said that during the next year it would focus its enforcement efforts on drug products most vulnerable to counterfeiting and diversion. These products include drugs with a high value in the U.S. market, drugs that are easily counterfeited and drugs with prior indicators -- such as drugs that were involved in diversion cases or counterfeiting -- including Tamiflu, Viagra, Cialis, Procrit, Zyprexa and Lamisil, officials said. (http://www.fdanews.com/did/5_114/)